About the job Regulatory Affairs Pharmacist To fulfill the position as regulatory affairs pharmacist for the company and any division within the group.
Key purpose Duties and responsibilities
Responsible for new product applications.
Compilation and submission of Post Registration amendments to ensure dossier compliance.
Responsible for pre and post registration SAHPRA Committee recommendation responses to ensure product registration.
Responsible for dossier updates, PI/PIL updates to ensure compliance with current legislation.
To ensure approval and compliance of printed packaging material and promotional marketing material.
Liaising with marketing department to facilitate timely launch of products.
Approval of master batch documentation prior to product production.
Responsible for SOP implementation/review, update and compliance.
Managing and maintaining regulatory documentation filing system.
Ensuring regulatory compliance and quality related records...